EP1406683A2 - Procede et dispositif d'occlusion intermittente du sinus coronarien - Google Patents

Procede et dispositif d'occlusion intermittente du sinus coronarien

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Publication number
EP1406683A2
EP1406683A2 EP02759855A EP02759855A EP1406683A2 EP 1406683 A2 EP1406683 A2 EP 1406683A2 EP 02759855 A EP02759855 A EP 02759855A EP 02759855 A EP02759855 A EP 02759855A EP 1406683 A2 EP1406683 A2 EP 1406683A2
Authority
EP
European Patent Office
Prior art keywords
pressure
coronary sinus
occlusion
perfusate
maxima
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
EP02759855A
Other languages
German (de)
English (en)
Other versions
EP1406683B1 (fr
Inventor
Werner Mohl
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Miracor Medical Systems GmbH
Original Assignee
Miracor Medizintechnik Handels und Entwicklungs GmbH
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Miracor Medizintechnik Handels und Entwicklungs GmbH filed Critical Miracor Medizintechnik Handels und Entwicklungs GmbH
Publication of EP1406683A2 publication Critical patent/EP1406683A2/fr
Application granted granted Critical
Publication of EP1406683B1 publication Critical patent/EP1406683B1/fr
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
    • A61M1/3613—Reperfusion, e.g. of the coronary vessels, e.g. retroperfusion
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12027—Type of occlusion
    • A61B17/1204—Type of occlusion temporary occlusion
    • A—HUMAN NECESSITIES
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    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12099—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
    • A61B17/12109—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel
    • A—HUMAN NECESSITIES
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    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
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    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/10—Location thereof with respect to the patient's body
    • A61M60/122—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body
    • A61M60/126—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable via, into, inside, in line, branching on, or around a blood vessel
    • A61M60/135—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable via, into, inside, in line, branching on, or around a blood vessel inside a blood vessel, e.g. using grafting
    • A61M60/143—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable via, into, inside, in line, branching on, or around a blood vessel inside a blood vessel, e.g. using grafting inside the coronary sinus, e.g. for pressure-controlled intermittent coronary sinus occlusion
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    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
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    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/30—Medical purposes thereof other than the enhancement of the cardiac output
    • A61M60/31—Medical purposes thereof other than the enhancement of the cardiac output for enhancement of in vivo organ perfusion, e.g. retroperfusion
    • A61M60/32—Medical purposes thereof other than the enhancement of the cardiac output for enhancement of in vivo organ perfusion, e.g. retroperfusion of heart muscle tissues, e.g. using coronary sinus occlusion
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    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/50—Details relating to control
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    • A61M60/531—Regulation using real-time patient data using blood pressure data, e.g. from blood pressure sensors
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    • A61B2017/00681—Aspects not otherwise provided for
    • A61B2017/00694—Aspects not otherwise provided for with means correcting for movement of or for synchronisation with the body
    • A61B2017/00703—Aspects not otherwise provided for with means correcting for movement of or for synchronisation with the body correcting for movement of heart, e.g. ECG-triggered
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    • A61M25/00—Catheters; Hollow probes
    • A61M2025/0001—Catheters; Hollow probes for pressure measurement
    • A61M2025/0003—Catheters; Hollow probes for pressure measurement having an additional lumen transmitting fluid pressure to the outside for measurement
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    • A61M25/00—Catheters; Hollow probes
    • A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
    • A61M25/0023—Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
    • A61M25/0026—Multi-lumen catheters with stationary elements
    • A61M2025/0036—Multi-lumen catheters with stationary elements with more than four lumina
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    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M25/1011—Multiple balloon catheters
    • A61M2025/1015—Multiple balloon catheters having two or more independently movable balloons where the distance between the balloons can be adjusted, e.g. two balloon catheters concentric to each other forming an adjustable multiple balloon catheter system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M2025/1043—Balloon catheters with special features or adapted for special applications
    • A61M2025/1052—Balloon catheters with special features or adapted for special applications for temporarily occluding a vessel for isolating a sector
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/33—Controlling, regulating or measuring
    • A61M2205/3331—Pressure; Flow
    • A61M2205/3344—Measuring or controlling pressure at the body treatment site
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/33—Controlling, regulating or measuring
    • A61M2205/3331—Pressure; Flow
    • A61M2205/3348—Pressure measurement using a water column
    • A—HUMAN NECESSITIES
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    • A61M2205/00—General characteristics of the apparatus
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    • A—HUMAN NECESSITIES
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    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/50—General characteristics of the apparatus with microprocessors or computers
    • A61M2205/52—General characteristics of the apparatus with microprocessors or computers with memories providing a history of measured variating parameters of apparatus or patient
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61M25/00—Catheters; Hollow probes
    • A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
    • A61M25/0023—Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
    • A—HUMAN NECESSITIES
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    • A61M25/00—Catheters; Hollow probes
    • A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
    • A61M25/0023—Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
    • A61M25/0026—Multi-lumen catheters with stationary elements
    • A61M25/0032—Multi-lumen catheters with stationary elements characterized by at least one unconventionally shaped lumen, e.g. polygons, ellipsoids, wedges or shapes comprising concave and convex parts
    • A—HUMAN NECESSITIES
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    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/20—Type thereof
    • A61M60/247—Positive displacement blood pumps
    • A61M60/253—Positive displacement blood pumps including a displacement member directly acting on the blood
    • A61M60/268—Positive displacement blood pumps including a displacement member directly acting on the blood the displacement member being flexible, e.g. membranes, diaphragms or bladders
    • A61M60/274—Positive displacement blood pumps including a displacement member directly acting on the blood the displacement member being flexible, e.g. membranes, diaphragms or bladders the inlet and outlet being the same, e.g. para-aortic counter-pulsation blood pumps
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    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
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    • A61M60/833—Occluders for preventing backflow

Definitions

  • the invention relates to a method for intermittent occlusion of the coronary sinus, in which the coronary sinus is occluded with an occlusion device, the fluid pressure in the occluded coronary sinus is measured continuously, and the occlusion of the coronary sinus is canceled as a function of at least one parameter derived from the pressure measurement values, and one Device for the intermittent occlusion of the coronary sinus.
  • a balloon catheter is guided under X-ray control into the area of the stenosis of the coronary artery and the arteriosclerotic plaque is compressed by inflating the balloon located at the end of the catheter.
  • PTCA percutaneous transluminal coronary angioplasty
  • a balloon catheter is guided under X-ray control into the area of the stenosis of the coronary artery and the arteriosclerotic plaque is compressed by inflating the balloon located at the end of the catheter.
  • PTCA percutaneous transluminal coronary angioplasty
  • a retroinfusion of arterial blood or other nutritive fluids into a vein of the relevant ischemia area of the myocardium has been carried out for some time.
  • the blood is pumped through the appropriate vein into the nutritive capillaries of the ischemia area and thus supplies the myocardium in this region with oxygen and substrates.
  • a device for retroinfusing coronary veins has become known, for example, from US Pat. No. 4,934,996, with which a pressure-controlled intermittent coronary sinus occlusion can be carried out.
  • the device comprises a device for occluding the sinus such as an inflatable balloon catheter, a pressure measuring device for measuring the fluid pressure within the coronary sinus and a control device which generates trigger signals for the occlusion device in order to trigger or cancel an occlusion.
  • the control device is designed such that the pressure maximum measured during each heartbeat in the coronary sinus, a plateau value of the pressure maxima of successive heartbeats is calculated and the occlusion of the coronary sinus is eliminated on the basis of the plateau value of the pressure maxima.
  • the occlusion of the coronary sinus causes an increase in pressure and subsequently a retroperfusion of blood through the corresponding vein into the nutritive capillaries of the ischemic area, so that these areas can be supplied with nutrients.
  • the retroperfused blood is flushed out, while the waste products of the metabolism are removed at the same time.
  • a systolic pressure curve is thus calculated on the basis of the measurement of the pressure maximum in the coronary sinus during each heartbeat, the intermittent occlusion being controlled as a function of the plateau value of the systolic pressure curve.
  • the course of the estimated systolic pressure curve also allows conclusions to be drawn about the performance of the heart, for example the slope of the curve representing the contractility of the heart.
  • the slope the curve naturally also has an influence on the level of the plateau value, a lower plateau value being achieved in the case of a flatter curve, the plateau also being reached after a longer period of time after initiation of the occlusion compared to a healthy heart.
  • the curve is also shifted if a coronary artery is temporarily closed during an interventional action such as PTCA or stenting, or for a longer period due to a complication, so that the pressure curve rises more slowly and also takes longer to reach the plateau.
  • the aim of the present invention is to propose a method or a device for the intermittent occlusion of the coronary sinus, which ensures an adequate retrograde supply of the ischemic area with blood even when the pressure curve is changed by the closure of a coronary vessel. Furthermore, in comparison to the known devices, a longer intervention should also be possible on the arterial side without causing tissue infarction in the affected myocardial regions.
  • the diagnostic component of intermittent occlusion known, for example, from US 4,887,608 should continue to be maintained.
  • the method according to the invention essentially consists in introducing a perfusate into the occluded coronary sinus or at least one vein opening into the coronary sinus, the regulation of the amount of perfusate introduced being carried out taking into account at least one parameter derived from the pressure measurement values.
  • the device according to the invention has an occlusion device for occlusion of the coronary sinus, a control device for triggering or canceling the occlusion and a pressure measuring device for detecting the fluid pressure in the coronary sinus during the occlusion and is characterized in that one in the coronary sinus or one in the Coronary sinus vein that can be inserted and filled with a perfusate and a pump connected to a control device it is provided for the perfusate that the pressure measuring device has a memory for pressure measured values and is connected to a computing unit for calculating at least one parameter derived from the pressure measured values, the regulation of the amount of perfusate introduced taking into account the parameter derived from the pressure measured values.
  • a perfusate is now introduced into the occluded coronary sinus or at least one vein opening into the coronary sinus during the occlusion, the regulation of the amount of perfusate introduced being carried out taking into account at least one parameter derived from the pressure measurement values.
  • the systolic or diastolic pressure curve which has become flatter due to the coronary vascular occlusion, can be raised again, so that the pressure level corresponds to a normal or setpoint value and sufficient retroperfusion into the ischemic area is ensured.
  • the amount of perfusate introduced must be regulated in such a way that the retroinfusion flow is neither too low nor too high. If the retroinfusion flow were too low, the venous pressure would be too low, so that an adequate supply of oxygen to the myocardium is not guaranteed and the myocardial function in the ischemic area cannot be maintained. If the infusion flow is too high, i.e.
  • the regulation of the quantity of perfusate is dependent on at least one parameter derived from the pressure measurement values made, several options are conceivable here. For example, a fixed limit value can be specified for the individual pressure measurement values, the amount of perfusate introduced no longer being increased if these limit values are exceeded.
  • a fixed limit value can be specified for the individual pressure measurement values, the amount of perfusate introduced no longer being increased if these limit values are exceeded.
  • the local maxima of the pressure measurement values of successive heartbeats rise according to an exponential curve and approach a plateau value, so that it is difficult to specify a controlled variable that is independent of the respective absolute pressure that prevails in the occluded coronary sinus. It is therefore advantageously carried out in such a way that the derivative of the liquid pressure curve over time is selected as the parameter derived from the pressure measurement values.
  • the device is developed in such a way that a time stamp is assigned to the pressure measurement values stored in the memory and the memory is connected to the computing unit for calculating the derivation of the liquid pressure curve over time.
  • a controlled variable is now specified with which it is possible to regulate the amount of perfusate introduced independently of the respective absolute pressure value.
  • the time derivative of the pressure curve reflects the slope of the pressure curve and indirectly allows a statement about the current pressure level and the rate of pressure rise within a heartbeat, so that if the pressure curve is not steep enough, the perfusion flow must be increased in order to obtain values that correspond to a healthy heart and allow compensation for the deficit in arterial blood flow caused by the occlusion of a coronary vessel.
  • the time derivative of the pressure curve as a controlled variable is also advantageous because it enables an optimal setting of the occlusion time.
  • the occlusion time is the manipulated variable and not the internal vessel pressure in the control method according to the invention. It should be ensured that the internal vessel pressure has reached a plateau value when the desired occlusion time is reached.
  • the procedure can preferably also be such that the local maximum occurring within a heartbeat and / or local minimum of the derivation of the liquid pressure curve over time is selected as the parameter derived from the pressure measurement values.
  • the device is developed in such a way that the computing unit has a comparison circuit for determining the local maximum and / or local minimum of the derivation of the fluid pressure curve occurring over time, the regulation of the amount of perfusate introduced depending on the local maxima and / or local minima is made.
  • the local maximum or minimum of the time derivative allows a precise description of the pressure curve and, in particular, the steepness of the pressure increase or pressure drop, so that this characteristic value is also very well suited for regulating the amount of perfusate introduced. This reduces the amount of data to be processed or evaluated in the control device and still achieves a precise curve description.
  • the device is further developed such that the computing unit comprises an evaluation circuit which mathematically estimates a plateau value of the local pressure maxima and / or local pressure minima of the derivation of the liquid pressure curve over time, and with the pump for regulating the amount of perfusate introduced as a function of this Plateau value interacts.
  • This preferred type of control is therefore based on the plateau value of the extreme values of the time derivative of the pressure curve, this plateau value essentially being reached at a time when the systolic or diastolic pressure curve also reaches a plateau value.
  • the plateau value is continuously calculated using the current pressure values.
  • the regulation is preferably carried out by comparing the local maxima and / or local minima of the derivation of the liquid pressure curve according to time and / or their plateau values with a target value.
  • the device is further developed in such a way that the computing unit comprises a comparison circuit for comparing the local maxima and / or local minima of the derivation of the liquid pressure curve according to time and / or its plateau values with a stored target value.
  • the target value can be, for example, a value corresponding to a healthy heart or also a value that was measured in the patient concerned before the intervention.
  • another characteristic variable derived from the pressure measured values can be used, for which purpose the procedure is such that a plateau value of the pressure minima and / or a plateau value of the pressure maxima of successive heartbeats is computationally estimated from the liquid measured values and is used as a parameter for regulating the amount of perfusate introduced.
  • the device is designed in such a way that the pressure measuring device has a memory for local maxima of the pressure measured values and the computing unit comprises an evaluation circuit which calculates a plateau value of the pressure maxima of successive heartbeats, and with the pump for regulating the amount of perfusate introduced as a function of the plateau value of the pressure maxima interacts.
  • the plateau values can in this case be estimated in a simple manner on the basis of the measured values of the pressure minima or pressure maxima, the computational estimation of the plateau values preferably being carried out by fitting the pressure maxima or minima into an exponential curve.
  • the estimation of the respective plateau value is therefore based on a mathematical approximation method, the plateau value being recalculated on the basis of the pressure measurements during each heartbeat. If the systolic pressure curve is increased by the additional introduction of perfusate, the diastolic pressure curve naturally also increases, in both cases after a certain time a plateau value for the pressure maxima and for the pressure minima is reached.
  • the systolic plateau but also the diastolic plateau can be calculated and the trend of the two pressure curves towards each other can be evaluated in order to determine the respective optimum of the occlusion time and the retrograde infusion flow. If the optimum amount of perfusion flow is exceeded, the plateau value for the pressure maxima generally remains constant, whereas the plateau value for the pressure minima continues to increase. In this sense, the quantity of perfusate introduced is preferably controlled in such a way that the difference between the plateau values of the pressure minima and the pressure maxima is calculated and the quantity of perfusate introduced is increased as long as the difference remains constant or becomes larger.
  • the device is developed in such a way that the control device has a comparison circuit for comparing the plateau values of the pressure minima and the pressure maxima and interacts with the pump for regulating the amount of perfusate introduced as a function of the difference between the pressure maxima and the pressure minima, the amount of perfusate introduced increasing as long as the difference remains constant or becomes larger.
  • the perfused fluid flow is thus slowly increased as long as the difference between the plateau values of the pressure minima and the pressure maxima remains constant or becomes larger. If this is no longer the case, the optimum perfusion flow has been reached and the amount of perfusate introduced is therefore kept constant.
  • the optimal determination of the occlusion times is also important, and in this connection the procedure is such that the pressure maxima of successive heartbeats are compared with the plateau value of the pressure maxima and, when a predetermined percentage of the plateau value of the pressure maxima is reached, the occlusion of the Coronary sinus is canceled, preferably the percentage greater than 70 and less than 98 is selected.
  • the device is preferably developed in such a way that the control device is connected to the control device for triggering and releasing the occlusion of the occlusion device, the occlusion being released when the pressure maxima of successive heartbeats reach a predetermined percentage of the plateau value of the pressure maxima, the percentage is greater than 70 and less than 98.
  • compositions can preferably be added to the perfusate.
  • Such pharmaceuticals can, for example, agents for dissolving thrombi, but also therapeutic or diagnostic agents, e.g. Anticoagulant, contrast agent or beta blocker.
  • the perfusate is preferably introduced directly into the area of the vessels to be activated, for which purpose the line that can be supplied with a perfusate is displaceably arranged relative to the occlusion device and can be advanced directly into the area of the vessels to be activated.
  • the perfusate can be introduced in a targeted manner at the desired location, so that the ventricular pressure can be overcome directly in the risk area, ie in the area to be activated. It seems advantageous that a local separation between the perfusate introduction and the occlusion device is created.
  • the perfusion catheter can be advanced, for example, into the coronary vein circulation, and the perfusion can be carried out as a function of the resistance to perfusion.
  • the pressure measurement is preferably carried out in the area of the occlusion device, so that a local separation between the pressure measurement and the introduction of the perfusate is achieved and the pressure measurement is prevented from being influenced.
  • An optimization or additional control can preferably be carried out in the context of the invention in such a way that the liquid pressure in an arterial vessel of the heart is additionally measured and the regulation of the amount of perfusate introduced is additionally carried out taking into account the arterial pressure measured values, or in addition a pressure measuring device for Detection of the fluid pressure in an arterial vessel of the heart is provided and the additional pressure measuring device is connected to the computing unit, the regulation of the amount of perfusate introduced additionally taking into account the arterial pressure measured values.
  • the amount of perfusate introduced can be regulated in the manner of a closed loop, additional diagnostic and control options being opened up by the expanded control loop.
  • control device can represent separate structural units, but alternatively the control device can comprise the regulating device for the pump and / or the computing unit.
  • FIG. 1 shows a diagram of a heart with a device for intermittent occlusion of the coronary sinus
  • FIGS. 2 and 3 show comparative representations of the heart tissue
  • FIGS. 4 and 5 show a graphical representation of the heart tissue 6 shows the course of the pressure plateau
  • FIG. 7 shows the course of the pressure rise time
  • FIG. 8 shows a section through the distal end of a catheter used with an expanded balloon
  • FIG. 9 shows a section along the line IX-IX of FIG expanded balloon
  • FIG. 10 shows a modified design in a section along line XX of FIG. 8.
  • Fig. 1 the device for intermittent occlusion of the coronary sinus is shown schematically, wherein a multi-lumen catheter 1, the distal end 2 of which is inserted into the coronary sinus of the heart 3 via the atrium, can be seen.
  • the proximal end 4 of the catheter 1 has a balloon inflation lumen 5 which is connected to a pump 6.
  • the pressure prevailing at the distal end 2 of the catheter 1 is recorded by a pressure measuring device 7, the pressure measuring device also having a memory for the measured values determined.
  • the respective pressure measurement values are fed to a control unit 8, which contains a circuit to supply control signals via line 9 for starting and stopping the pump 6.
  • the pressure measuring device 7 is also connected to a control device 10 which serves to control a further pump 11 and which regulates the amount of perfusate delivered by the pump 11 via a further lumen 12 of the catheter 1.
  • Fig. 2 shows a comparative representation of the condition of the heart tissue in different situations.
  • 2a shows the normal situation in which the heart tissue 13 is adequately supplied from the arterial side 14 via arteries 15, 16 and 17.
  • the veins are shown schematically at 18, 19 and 20.
  • 2b shows the state of ischemia, in which the middle artery 16 is closed or narrowed. The corresponding tissue area is inadequate or not supplied with blood at all. There is no retrograde perfusion in the ischemic area.
  • 2c now shows the situation which arises when the invention is applied.
  • the artery 16 is in turn closed, so that an adequate supply of the corresponding tissue part would not be provided.
  • blood is now retro-infused into the ischemic area, as indicated schematically by arrow 21, the occlusion of the vein being shown schematically at 22.
  • FIG. 3 shows an enlarged illustration according to FIG. 2c, in which the pressure curve in the vein and the backflow of the retro-infused blood into the ischemic area, which increases with the pressure, can be seen.
  • the closed artery 16 is again visible, as is the vein 19, through which the perfusate penetrates into the tissue in the direction of the arrow 21.
  • the pressure curve shown on the right in FIG. 3 can be measured in the occluded vein, with more ischemic area being reached with increasing pressure maxima.
  • FIG. 4 shows the pressure curve detected by the measuring device 7, the beginning of the occlusion being represented by T0.
  • a series of systolic pressure peaks 23 and a series of diastolic valleys 24 can be seen.
  • the pulse period 25 of the heartbeat is represented by the time between successive peaks or successive troughs.
  • Pd (t) Ad (le -t ' Tc i)
  • Ad the asymptotic plateau of the pressure valleys
  • Td the time to reach the plateau.
  • FIG. 6 shows the course of the pressure plateau over the entire time of an intervention on a coronary artery.
  • the intervention being terminated at point 32 and the closure of the coronary artery being released.
  • FIGS. 8 to 10 now show a multi-lumen balloon catheter which can be used in the process.
  • the distal end of a catheter 1 is designated by 2.
  • different outlet openings 34, 35, 36 or 37 can be connected to mutually different lumens, so that in this way the separate supply of pharmacological substances or the supply of a perfusate is just as successful as, for example, the determination of pressure measurement values via the in a lumen holding liquid column.
  • the distal end of the catheter 2 is slidably and sealingly in an expandable balloon 38 in the direction of the double arrow 39, the seal being denoted by 40.
  • a further lumen 41 for a pressure measurement can also be seen.
  • the balloon 38 can be expanded, whereupon the respectively suitable position of the distal end 2 or of the outlet openings or orifices 34, 35, 36 or 37 by axially displacing the distal end 2 relative to the balloon 38 can be set in the direction of the double arrow 39. If the distal end is withdrawn with a suitable choice of the spacings of the openings 34, 35, 36 or 37 in such a way that part of the openings or openings is sealed by the balloon, only the free through openings or openings 35, 36 or remain 37 in direct contact with the surrounding fluid and in particular with the blood in the bloodstream of a blood vessel.
  • the inner wall adjacent to the displaceable part of the catheter carries axial lumens 41, via which pressure measurement values can be obtained, for example.
  • the pressure medium for expanding the balloon 38 can also be supplied via one or more such axial channels 41.
  • a multi-lumen catheter 1 is shown, the individual lumens of which are designated 43, 44 and 45.
  • the individual lumens can be connected to different openings or openings 34, 35, 36 and 37, as can be seen in FIG. 8, wherein wires for the electrical contacting of measuring sensors can also be arranged in such lumens.

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  • Health & Medical Sciences (AREA)
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  • Molecular Biology (AREA)
  • Transplantation (AREA)
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  • Optics & Photonics (AREA)
  • External Artificial Organs (AREA)
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Abstract

L'invention concerne un procédé d'occlusion intermittente du sinus coronarien, selon lequel le sinus coronarien est obturé au moyen d'un dispositif d'occlusion, la pression du liquide dans le sinus coronarien fermé est mesurée en permanence, l'occlusion du sinus coronarien est interrompue en fonction d'au moins un paramètre dérivant des valeurs de mesures de pression. Selon le procédé, un perfusat est introduit dans le sinus coronarien obturé ou au moins dans une veine débouchant dans le sinus coronarien, la régulation de la quantité de perfusat introduit étant fonction d'au moins un paramètre dérivant des valeurs de mesures de pression. Le dispositif d'occlusion intermittente du sinus coronarien comporte un appareillage d'occlusion, un dispositif de commande pour déclencher et arrêter l'occlusion et un dispositif de mesure de pression pour saisir la pression du liquide dans le sinus coronarien pendant l'occlusion. Un conduit chargé d'un perfusat est introduit dans le sinus coronarien ou dans une veine débouchant dans le sinus coronarien, une pompe reliée au dispositif de régulation servant au transport du perfusat. Le dispositif de mesure de pression comprend une mémoire pour conserver les valeurs de mesures de pression et il est relié à une unité de calcul pour calculer au moins un paramètre dérivant des valeurs de mesures de pression. La régulation de la quantité de perfusat introduite tient compte du paramètre dérivant des valeurs de mesures de pression.
EP02759855A 2001-07-17 2002-07-17 Dispositif d'occlusion intermittente du sinus coronarien Expired - Lifetime EP1406683B1 (fr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
AT11132001 2001-07-17
AT0111301A AT410396B (de) 2001-07-17 2001-07-17 Vorrichtung für die intermittierende okklusion des koronarsinus
PCT/AT2002/000212 WO2003008018A2 (fr) 2001-07-17 2002-07-17 Procede et dispositif d'occlusion intermittente du sinus coronarien

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EP1406683A2 true EP1406683A2 (fr) 2004-04-14
EP1406683B1 EP1406683B1 (fr) 2010-06-16

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US (1) US7331922B2 (fr)
EP (1) EP1406683B1 (fr)
JP (1) JP4106019B2 (fr)
AT (1) AT410396B (fr)
DE (1) DE50214494D1 (fr)
WO (1) WO2003008018A2 (fr)

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Also Published As

Publication number Publication date
US7331922B2 (en) 2008-02-19
ATA11132001A (de) 2002-09-15
DE50214494D1 (de) 2010-07-29
AT410396B (de) 2003-04-25
US20040172004A1 (en) 2004-09-02
WO2003008018A2 (fr) 2003-01-30
JP2004534619A (ja) 2004-11-18
WO2003008018A3 (fr) 2003-04-17
EP1406683B1 (fr) 2010-06-16
JP4106019B2 (ja) 2008-06-25

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